D-mannose for the Prevention of UTIs in Multiple Sclerosis

NCT02490046 | Unknown Phase 1 DMC

• 1 other identifier: 14/0384
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to explore the feasibility of using D-mannose, a commonly used food supplement, in persons with multiple sclerosis reporting recurrent urinary tract infections. Twenty persons with multiple sclerosis (10 patients using catheters and 10 not using catheters) reporting recurrent urinary tract infections will receive D-mannose 1.5 grams twice daily for 16 weeks duration. This will be explored through:

1. 1.Assessing compliance to a 16-week course of D-mannose
2. 2.Quantifying the number of prescriptions for antibiotics during the 16 weeks course of D-mannose

Conditions

Multiple Sclerosis; Recurrent Urinary Tract Infections

Keywords

D mannose; multiple sclerosis; recurrent urinary infections

Outcome Measures

Primary Outcomes (1)

• Compliance (self-usage diary and weight of returned containers of D-mannose)

  Compliance to a 16-week course of D-mannose as assessed using a self-usage diary and weight of returned containers of D-mannose. The number of days the participant does not use D-mannose and reasons for non-use will be noted.

  16 weeks

Secondary Outcomes (1)

• Antibiotic prescription (Number of prescriptions for antibiotics required)

  16 weeks

Study Arms (2)

MS and rec UTIs not using a catheter

EXPERIMENTAL

people with multiple sclerosis and recurrent urinary tract infections with spontaneous voiding Intervention- will be given D-mannose

Dietary Supplement: D Mannose

MS and rec UTIs using a catheter

EXPERIMENTAL

people with multiple sclerosis and recurrent urinary tract infections using either urethral or suprapubic indwelling catheter or intermittent catheterisation Intervention- will be given D-mannose

Dietary Supplement: D Mannose

Interventions

D Mannose DIETARY_SUPPLEMENT

Patients in both arms will receive D-mannose powder to be used 1.5 gm (one level-teaspoon) twice daily, to be added to any beverage, for 16 weeks.

MS and rec UTIs not using a catheter; MS and rec UTIs using a catheter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a known diagnosis of Multiple sclerosis (all stages) who have been clinically stable for at least three months and reporting lower urinary tract symptoms.
• Patient with recurrent urinary tract infections, defined as having at least two urinary tract infections in the preceding six months or three or more urinary tract infections in the preceding one year. Urinary tract infections were defined retrospectively by patient self-report and confirmation by urine culture.
• Age over 18 years and below 65
• Females of childbearing potential using effective contraception if sexually active - oral contraceptive pill (\> 3 months use), condoms, intrauterine contraceptive device, depot injection

You may not qualify if:

• Pregnancy or planning pregnancy
• Breastfeeding
• History of congenital urinary tract anomalies or interstitial cystitis
• History of diabetes mellitus
• Receiving antibiotic prophylaxis or cranberry extract preparations
• Current urinary tract infection
• Current vaginal infection
• Any known allergies to D-mannose

Sponsors & Collaborators

• University College, London: lead
• UCLH: collaborator

Study Sites (1)

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

RECRUITING

Related Publications (19)

• Nakipoglu GF, Kaya AZ, Orhan G, Tezen O, Tunc H, Ozgirgin N, Ak F. Urinary dysfunction in multiple sclerosis. J Clin Neurosci. 2009 Oct;16(10):1321-4. doi: 10.1016/j.jocn.2008.12.012. Epub 2009 Jun 27.

  PMID: 19560927 BACKGROUND

• de Seze M, Ruffion A, Denys P, Joseph PA, Perrouin-Verbe B; GENULF. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Mult Scler. 2007 Aug;13(7):915-28. doi: 10.1177/1352458506075651. Epub 2007 Mar 15.

  PMID: 17881401 BACKGROUND

• The prevention and management of urinary tract infections among people with spinal cord injuries. National Institute on Disability and Rehabilitation Research Consensus Statement. January 27-29, 1992. J Am Paraplegia Soc. 1992 Jul;15(3):194-204. doi: 10.1080/01952307.1992.11735873.

  PMID: 1500945 BACKGROUND

• Hoffman JM, Wadhwani R, Kelly E, Dixit B, Cardenas DD. Nitrite and leukocyte dipstick testing for urinary tract infection in individuals with spinal cord injury. J Spinal Cord Med. 2004;27(2):128-32. doi: 10.1080/10790268.2004.11753743.

  PMID: 15162883 BACKGROUND

• Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.

  PMID: 19403235 BACKGROUND

• Fowler CJ, Panicker JN, Drake M, Harris C, Harrison SC, Kirby M, Lucas M, Macleod N, Mangnall J, North A, Porter B, Reid S, Russell N, Watkiss K, Wells M. A UK consensus on the management of the bladder in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 May;80(5):470-7. doi: 10.1136/jnnp.2008.159178.

  PMID: 19372287 BACKGROUND

• Leary SM, Porter B, Thompson AJ. Multiple sclerosis: diagnosis and the management of acute relapses. Postgrad Med J. 2005 May;81(955):302-8. doi: 10.1136/pgmj.2004.029413.

  PMID: 15879043 BACKGROUND

• Hennessey A, Robertson NP, Swingler R, Compston DA. Urinary, faecal and sexual dysfunction in patients with multiple sclerosis. J Neurol. 1999 Nov;246(11):1027-32. doi: 10.1007/s004150050508.

  PMID: 10631634 BACKGROUND

• Correale J, Fiol M, Gilmore W. The risk of relapses in multiple sclerosis during systemic infections. Neurology. 2006 Aug 22;67(4):652-9. doi: 10.1212/01.wnl.0000233834.09743.3b. Epub 2006 Jul 26.

  PMID: 16870812 BACKGROUND

• Buljevac D, Flach HZ, Hop WC, Hijdra D, Laman JD, Savelkoul HF, van Der Meche FG, van Doorn PA, Hintzen RQ. Prospective study on the relationship between infections and multiple sclerosis exacerbations. Brain. 2002 May;125(Pt 5):952-60. doi: 10.1093/brain/awf098.

  PMID: 11960885 BACKGROUND

• Rakusa M, Murphy O, McIntyre L, Porter B, Panicker J, Fowler C, Scott G, Chataway J. Testing for urinary tract colonization before high-dose corticosteroid treatment in acute multiple sclerosis relapses: prospective algorithm validation. Eur J Neurol. 2013 Mar;20(3):448-452. doi: 10.1111/j.1468-1331.2012.03806.x. Epub 2012 Jul 21.

  PMID: 22816507 BACKGROUND

• Everaert K, Lumen N, Kerckhaert W, Willaert P, van Driel M. Urinary tract infections in spinal cord injury: prevention and treatment guidelines. Acta Clin Belg. 2009 Jul-Aug;64(4):335-40. doi: 10.1179/acb.2009.052.

  PMID: 19810421 BACKGROUND

• Jepson RG, Williams G, Craig JC. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD001321. doi: 10.1002/14651858.CD001321.pub5.

  PMID: 23076891 BACKGROUND

• Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.

  PMID: 24402038 BACKGROUND

• Michaels EK, Chmiel JS, Plotkin BJ, Schaeffer AJ. Effect of D-mannose and D-glucose on Escherichia coli bacteriuria in rats. Urol Res. 1983;11(2):97-102. doi: 10.1007/BF00256954.

  PMID: 6346629 BACKGROUND

• Kranjcec B, Papes D, Altarac S. D-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trial. World J Urol. 2014 Feb;32(1):79-84. doi: 10.1007/s00345-013-1091-6. Epub 2013 Apr 30.

  PMID: 23633128 BACKGROUND

• Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.

  PMID: 11955556 RESULT

• Marrie RA, Cutter G, Tyry T, Vollmer T, Campagnolo D. Disparities in the management of multiple sclerosis-related bladder symptoms. Neurology. 2007 Jun 5;68(23):1971-8. doi: 10.1212/01.wnl.0000264416.53077.8b.

  PMID: 17548546 RESULT

• Phe V, Pakzad M, Haslam C, Gonzales G, Curtis C, Porter B, Chataway J, Panicker JN. Open label feasibility study evaluating D-mannose combined with home-based monitoring of suspected urinary tract infections in patients with multiple sclerosis. Neurourol Urodyn. 2017 Sep;36(7):1770-1775. doi: 10.1002/nau.23173. Epub 2016 Nov 4.

  PMID: 27813195 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Tract Infections

Interventions

Mannose

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Jalesh Panicker, MD,FRCP

  UCLH NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jalesh Panicker, MD, FRCP

CONTACT

0203 448 4713; j.panicker@ucl.ac.uk

Véronique Phé, MD

CONTACT

0203 448 4713; Veronique.Phe@uclh.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: July 3, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

GB (1)